Device for guiding a tubular element near an access point into the body of a human or animal being and for disinfecting the tissue surrounding the access point

Abstract

A device (100) for guiding a tubular element (10) near an access point into a human or animal body and for disinfecting tissue around the access point by applying light comprises a base (120) adapted to be attached to the human or animal body near the access point and an upper part (140) adapted to be removably attached to the base (120). The base (120) and / or the upper part (140) form a guide for the tubular element (10). The base (120) and / or the upper part (140) guide at least one optical fiber (131.1...4) along the guide for the tubular element (10), the optical fiber (131.1...4) having at least one emission surface for emitting light to illuminate tissue around the access point when the base (120) is attached to the body. The upper part (140) is adapted to be attached to and removed from the base (120) after the tubular element (10) has been introduced into the human or animal body. The device (100) ensures proper guidance of the tubular element (10) and defines a controlled environment for disinfection by light emitted by the optical fiber(s) (131.1...4). This results in a reliable disinfection. At the same time, the device (100) enables an easy and foolproof handling.

Description

Technical Field

[0001] The present invention relates to a device for guiding a tubular element near an entry point into a human or animal body and for disinfecting tissue around the entry point by applying light. Background Technology

[0002] Many medical applications involve introducing tubular elements into the human or animal body. In some cases, these tubular elements remain in the body for a considerable period of time. As an example, intravenous infusion is a widely used technique for the direct, automated delivery of life-saving medications and fluids directly into a patient's body. This procedure involves a catheter that forms such a tubular element, with one end of the catheter inserted into a vein located at an appropriate site, such as the subclavian, jugular, femoral, or peripheral vein, depending on the specific treatment. A primary example of such a catheter is the central venous catheter (CVC), which has several subtypes, such as tunneled CVCs, non-tunneled CVCs, peripherally inserted central catheters (PICCs), and implantable ports. The specific choice of CVC is determined by the physician based on the implantation site and the estimated duration of use, which can range from a few days to several months.

[0003] However, the use of catheters or other tubular elements (especially over longer periods) is associated with a range of infections such as bloodstream infections commonly referred to as centerline-associated bloodstream infection (CLABSI) and catheter-associated bloodstream infection (CRBSI).

[0004] CLABSI is a hospital-acquired infection (HAI) that can occur in both intensive care unit (ICU) and non-ICU settings. Furthermore, CLABSI also occurs in non-hospital settings where a central vena cava (CVC) is inserted into the patient for ongoing treatment, such as in a home or nursing home. CLABSI typically leads to prolonged hospital stays in the ICU and associated treatment costs, averaging over 10 days and $46,000 per patient in the United States. In terms of HAI, approximately 1.7 million cases are reported annually in the United States and 4.2 million annually in the European Union ["Health care-associated infections fact sheet." World Health Organization 4 (2015)]. Given these circumstances, it is crucial not only to effectively treat such serious health problems but also to strive to prevent such infections from occurring.

[0005] Current recommendations from medical experts call for a comprehensive, multimodal approach [Zingg, Walter et al., “Hospital-wide multidisciplinary, multimodal intervention program to reduce central venous catheter-associated bloodstream infection.” PLoS one 9.4 (2014): e93898], which comprises several therapies to ensure safe intravenous procedures. These therapies include careful skin preparation, catheter stabilization and fixation, patient cleansing, and antibiotic treatment. While guidelines for these integrated strategies have demonstrated effectiveness, they place a significant burden on healthcare workers, in addition to the required specialized training and education, to ensure consistency.

[0006] Over the past few decades, various technological solutions have emerged to combat such infections [CDC - Centers for Disease Control and Prevention. "Guidelines for the Prevention of Intravascular Catheter-Related Infections" (2011)]. One significant improvement involves adding an antifouling coating to the inner lumen of the catheter. This technology slows the rate of biofilm formation on the catheter surface, thus delaying the residence time for CLABSI.

[0007] Similar measures can be taken in other applications where tubular elements enter the human or animal body and remain in their position for extended periods of time.

[0008] Another promising solution is provided by phototherapy, which utilizes the bactericidal properties of light at certain wavelengths. A suitable candidate is ultraviolet-C (UVC) radiation, which ranges from 100 to 280 nm and is known to have both antibacterial and bactericidal effects.

[0009] In the applicant's WO 2022 / 248691 A1, a system for disinfecting skin tissue around a catheter using UVC radiation is disclosed. The system includes an adapter defining a catheter inlet opening for the catheter to enter into the adapter and a catheter outlet opening for the catheter to exit from the adapter. The adapter includes an outer surface and an inner surface defining an internal cavity for receiving at least a section of the catheter, wherein the internal cavity extends from the catheter inlet opening to the catheter outlet opening. The system further includes at least one light source for emitting UVC light, wherein the light source is arranged such that the UVC light is emitted away from the adapter. This disclosure discloses several proposals regarding the mechanical construction of the adapter and the supply and distribution of UVC light.

[0010] The announcement presents a very promising approach to combating infection; however, usability studies have shown that the system can be improved in terms of ease of use and application security. Summary of the Invention

[0011] The object of the present invention is to create an apparatus relating to the initially mentioned technical field that allows for reliable disinfection of tissue around the point of entry of a tubular element into a human or animal body, and is easy and safe to use.

[0012] The solution of the present invention is specifically described by the features of claim 1. According to the present invention, the device comprises: a) The base, adapted for attachment to a human or animal body near the point of entry; and b) The upper part is adapted to be removably attached to the base.

[0013] Different techniques can be used to attach the base to the human or animal body. These specifically include the use of adhesives and / or suturing.

[0014] The base and / or upper portion form a guide for the tubular element. Therefore, in a first set of embodiments of the device of the present invention, the guide for the tubular element may be formed only by the upper portion. In a second set of embodiments, the guide for the tubular element may be formed only by the base. In a third set of embodiments, the guide for the tubular element may be formed by both the base and the upper portion, wherein both components may be designed to contact the tubular element along the guide along the tubular element or throughout its entire extension in a portion of the tubular element.

[0015] At least one optical fiber is guided along a guide for a tubular element at the base and / or upper portion. The optical fiber has at least one emitting surface for emitting light to illuminate tissue around the entry point when the base is attached to the body. Therefore, in a first set of embodiments, at least one optical fiber is guided in the base. In a second set of embodiments, at least one optical fiber is guided in the upper portion. In a third set of embodiments, at least one fiber is guided in the base, and at least one additional fiber is guided in the upper portion.

[0016] Furthermore, the upper portion is adapted to be attached to and removed from the base after the tubular element has been introduced into the human or animal body. Depending on the specific embodiment of the device and possibly the specific application, several methods of applying the device of the invention are available. In a first method, the tubular element is first introduced into the body and attached to the body by means known per se. After this, the base is applied and subsequently the upper portion is applied. In a second method, the tubular element is first introduced into the body and attached to the body using the base element. After this, the upper portion is applied. In a third method, the base is first attached to the body. In a second step, the tubular element is introduced and then attached to the base. Finally, the upper portion is applied.

[0017] Preferably, at least one optical fiber enters the base and / or upper portion from substantially the same direction as the tubular element and / or on the same surface as the tubular element. This improves the usability of the device. In particular, the optical fiber extends parallel to the guide for the tubular element, at least in sections of its path through the respective portions(s). In a preferred embodiment, at least one optical fiber exits the base and / or upper portion from substantially the same direction as the tubular element and / or on the same surface as the tubular element. This allows for efficient disinfection in the area around the tubular element and, in particular, around the point of entry into the body.

[0018] As explained in more detail below, at least one emitting surface may be located on the end face and / or the lateral surface of the optical fiber (end-emitting optical fiber), particularly in the distal region of the optical fiber (side-emitting fiber). If the device includes more than one optical fiber, the first group of fibers may be end-emitting, and the second group of fibers may be side-emitting. Furthermore, fibers that emit light through their lateral surfaces and through their distal ends may be used.

[0019] The upper part can be attached to the base in different ways, such as by using snap-fit ​​connection, press fit, shape fit with other means (e.g. screws), removable adhesive, etc.

[0020] The device of the present invention can be applied to various body areas. The tissue surrounding the entry point can be skin tissue or other tissues, such as tissues of the urethra, trachea, mouth, or nostrils.

[0021] Preferably, the tubular element is one of the following: a) Catheters, especially central venous catheters, catheters for external ventricular drainage, catheters for extracorporeal membrane oxygenation, catheters for dialysis (e.g., hemodialysis, peritoneal dialysis) or catheters for long-term drug administration. b) Lines used for transmitting electrical or optical signals, particularly lines used for transmitting electrical or optical signals to and / or from the brain of a human or animal or to an implanted medical device. c) Circuits used to specifically supply electrical energy to implanted medical devices.

[0022] Therefore, the present invention can be applied to a large number of different fields, including in particular: - Application of central venous catheters (CVCs); - Extracorporeal membrane oxygenation (ECMO); - External ventricular drainage (EVD); - Cardiac assist devices, such as left ventricular assist devices (LVADs); - Implantable brain-computer interfaces (BCIs), such as the solution developed by Neuralink, a company based in Fremont, California. And many more fields.

[0023] The device of the present invention can be used in particular to illuminate tissue around the point of entry with ultraviolet light, preferably UVC light, especially UVC light with a wavelength of 190-235 nm.

[0024] The device of the present invention ensures proper guidance of the tubular element and defines a controlled environment for sterilization by light emitted from (multiple) optical fibers. This results in reliable sterilization. Simultaneously, the device of the present invention enables easy and error-proof operation. In addition to preventing infection, the device of the present invention also helps reduce the risk of antimicrobial resistance (AMR) because it allows for reduced antibiotic administration.

[0025] Preferably, the guide for the tubular element is arranged such that, in at least one section, the center of the receiving space for the tubular element is at least 2 mm, and particularly at least 3 mm, from the attachment surface for attaching the device to the body of a person or animal.

[0026] The center of the receiving space is defined as the center point in a cross-section extending perpendicular to the (partial) longitudinal extension of the fiber. In the case of a fiber with a circular cross-section, the center of the receiving space coincides with the center of the fiber's cross-section. In the case of a fiber with a non-circular cross-section, the center of the receiving space is defined as the centroid of the corresponding cross-section of the fiber.

[0027] In the proximal section of the entry point into the human body, a tubular element is guided at a certain distance from the body surface to facilitate illumination of the tissues around the entry point, as this ensures that no body surface in this area is covered or obscured by the tubular element.

[0028] In a preferred embodiment, the guide for the tubular element includes a curved section that guides the received tubular element from an initial direction generally parallel to the attachment surface of the base to an inclined direction toward the entry point. The curved section may be defined by a single continuous element or by two or more cooperating elements that locally guide the tubular element and include an angle such that the tubular element presents a curved shape. It should be noted that additional sections may exist proximal to the initial direction, where the distance from the tubular element to the body surface is less than the distance at the location where the tubular element presents the initial direction, for example, when the tubular element, such as a conduit, is outside the device of the invention and attached to the body surface at a distance from the entry point into the body.

[0029] The curved section ensures proper guidance of the tubular element, thus avoiding kinking or excessive mechanical stress. The curved section provides a defined geometry for the tubular element near the entry point, which is beneficial for controlled light distribution and therefore ensures proper sterilization. Furthermore, the tubular element is arranged at a desired angle relative to the body surface at the entry point, which reduces the radial forces exerted by the tubular element on surrounding body tissues. Suitable angles may be, for example, 30-60°.

[0030] In a preferred embodiment, in the attachment configuration of the upper portion to the base, a curved section for the guide of the tubular element is formed between the lower guide in the base and the upper guide in the upper portion. This facilitates the reception of the tubular element in the device of the invention, as the element can be introduced into the lower guide in the base, and the upper portion is subsequently attached to the base, thereby accommodating the element between the lower and upper guides. Therefore, it is not required to thread the tubular element through an opening, and the lower and upper guides can, in principle, be formed of a rigid material.

[0031] In other embodiments, instead of having a separable upper portion, the upper portion and the base are attached to each other using a mechanism that allows relative movement (e.g., a hinge).

[0032] Specifically, at least one optical fiber is guided in the lower guide portion, and at least one additional optical fiber is guided in the upper guide portion. This allows for uniform illumination of the area surrounding the tubular element near the point of entry into the body. Specifically, the fiber extending in the upper guide portion has a larger cross-section than the fiber in the lower guide portion, or the number of fibers extending in the upper guide portion is greater than the number of fibers extending in the base. This is due to the fact that higher light intensity may be required at the emitting surface of the upper fibers, as the corresponding light typically illuminates a larger surface compared to the light emitted by the lower fibers and / or because the light emitted by (multiple) upper fibers is scattered to achieve uniform illumination, while the light emitted by (multiple) lower fibers can directly illuminate the corresponding area. In embodiments where the guide for the tubular element is not bent and / or formed respectively in the base or upper portion, it is also possible to arrange at least one optical fiber in the base and at least one additional optical fiber in the upper portion.

[0033] In a preferred embodiment, at least one emitting surface of at least one optical fiber is located at the distal end of the fiber, wherein the distal end is positioned in the region surrounding the distal end of the guide for the tubular element. This allows for simple design and uniform illumination of the area around the entry point. The main illumination direction may be parallel to the tubular element.

[0034] The region of the component surrounding the distal end of the fiber can be formed as a cavity, which can be formed of or coated with a scattering material. This improves the distribution of light emitted from the distal end.

[0035] In a preferred embodiment, at least two end-emitting optical fibers terminate in the region surrounding the distal end of the guide.

[0036] Specifically, the distal end of at least one fiber is substantially located at the distal end of the curved section of the guide, and is particularly at a certain distance from the body surface. Furthermore, the distal end of at least one fiber may be substantially outside the corresponding portion (base and / or upper part) of the device, meaning that the fiber is mechanically protected by the corresponding portion(s).

[0037] At least two end-emitting fibers can be supplied as a fiber bundle. This bundle can be split into individual fibers upstream of the device or only within the device.

[0038] At least two end-emitting fibers may also be supplied by a single fiber and connected to that single fiber via a splitter located upstream of or within the device.

[0039] Not all of the at least two optical fibers need to terminate in the region around the distal end of the guide and / or have a main illumination direction parallel to the tubular element. Some of the at least two optical fibers may include side-emitting surfaces and / or their main illumination directions may be directed to a scattering element for light distribution.

[0040] In a preferred embodiment, the device comprises a single optical fiber, particularly an end-emitting fiber. Using a single fiber and preferably an additional scattering surface avoids undesirable hot spots (illuminated by more than one light source) and poorly illuminated areas. Furthermore, it avoids the fiber coupling efficiency loss that occurs when using two or more fibers and reduces manufacturing complexity.

[0041] In a preferred embodiment, the base and / or upper portion form a flexible guide channel for guiding the tubular element, and the upper portion and / or base (i.e., another portion) includes clamping sections for selectively compressing the flexible guide channel and the tubular element housed within it, thereby locking the tubular element within the flexible guide channel. The flexibility of the guide channel allows the tubular element to be introduced and / or adjusted within it before (radially) compressing due to the engagement of the clamping sections, resulting in a frictional fit of the tubular element within the guide channel.

[0042] Preferably, the flexible guide channel is characterized by a continuous slit (particularly in the top region) extending along the entire length of the guide channel, which allows the tubular element to be introduced without having to be threaded through it.

[0043] In a preferred embodiment, a flexible guide channel is formed in the base, and a clamping section is formed in the upper portion. The upper portion is slidably attached to the base, wherein the sliding direction for attaching the upper portion to the base is specifically parallel to the extension of the guide for the tubular element. This allows for easy manipulation of the device of the invention and avoids potentially harmful mechanical impacts on the tubular element.

[0044] A first embodiment is possible, wherein the sliding direction extends from the proximal region of the guide to the distal region, and a second embodiment is possible, wherein the sliding direction extends from the distal region of the guide to the proximal region. It should be further noted that in some embodiments, the upper portion may be slidably inserted into the base, i.e., between the lower portion and the upper portion of the base, the upper portion may be partially or completely located above the upper portion.

[0045] Alternatively, the clamping section may be applied from above to the base with the flexible guide channel in a direction substantially perpendicular to or inclined relative to the guide (and body surface) for the tubular element.

[0046] Preferably, the base and / or upper surfaces illuminated by light emitted by the optical fibers are made of a biocompatible UVC-resistant material, particularly of a selection from the following materials: PTFE (especially e-PTFE or Spectralon), aluminum, alumina, magnesium oxide, titanium, titanium dioxide, and other ceramic materials.

[0047] This prevents material degradation. In particular, the material also possesses desirable optical properties, such as reflectivity of 98% or higher. For example, constructing the main optically relevant surfaces from sintered PTFE (e.g., Spectralon) sheets with a thickness of at least 0.75 mm ensures the desired reflectivity, biocompatibility, and resistance to UVC radiation, especially to far UVC radiation in the 200-220 nm range.

[0048] The coating can be applied to a substrate, specifically made of plastic or glass. In a preferred embodiment, the device of the invention includes a dome element for distributing light emitted by at least one optical fiber to homogenize illumination of the skin tissue surrounding the entry point. Specifically, the dome element is characterized by an inner surface made of or covered by a scattering material. Preferably, the dome includes concave sections (as seen from the body surface) to allow the collection and guidance of illuminated light to the tissue surrounding the entry point.

[0049] Preferably, the dome element comprises a surface made of a light-scattering material, wherein light emitted by at least one optical fiber is at least partially directed to the surface. Specifically, at least 50% of the light emitted by the fiber does not reach the area to be disinfected directly, but rather arrives after being scattered by the surface of the dome element. This ensures the uniformity of the illuminated light.

[0050] Such an arrangement is particularly advantageous if a single optical fiber is used, as it provides uniform illumination without significantly increasing complexity.

[0051] The scattering surface can be curved in two directions (non-zero Gaussian curvature) or in one direction (non-zero curvature, zero Gaussian curvature). This allows for the specialized tuning of the dome's optical properties. In other embodiments, the scattering surface is flat. This minimizes product complexity.

[0052] Alternatively or additionally, the guide section for the tubular element may be characterized by a scattering material and / or individual scattering elements arranged on the base and / or upper part.

[0053] In a preferred embodiment, the dome element includes at least one window that allows inspection of the tissue surrounding the access point. This facilitates the manipulation of the device, as it is no longer necessary to remove the device or any part thereof to inspect the tissue.

[0054] The window can be an opening; however, it is preferred if at least one window is covered by a transparent material. This protects the underlying tissue from harmful influences, such as bacteria. Preferably, the transparent material filters out potentially harmful components of the light used for tissue disinfection, such as UV components. Most preferably, the window is covered by a membrane made of a transparent material, particularly a breathable transparent material. Such membranes are available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0055] Instead of or in addition to a window, a portion or section of the device of the present invention may be selectively movable in order to remove obstruction of the line of sight to the point of entry and surrounding tissue.

[0056] In a preferred embodiment, the dome element is adapted to be selectively attached to the upper element. In principle, this allows for selective attachment of the dome or not, depending on the specific application. Furthermore, the dome element can be temporarily removed if the access point of the tubular element needs to be inspected.

[0057] The dome element can be configured such that there is a distance between the dome, which is attached to the upper element, and the body surface. This avoids mechanical interaction between the dome (which has the primary function of distributing light to uniformly illuminate the tissue around the entry point) and the body surface. Furthermore, it improves breathability and prevents fluid buildup within the dome, as the distance allows fluid to drain out.

[0058] In other embodiments, the dome may be selectively attached to the base or constructed integrally with the base or upper elements.

[0059] In a preferred embodiment, at least one optical fiber (or at least one of a plurality of fibers) is guided within the dome element. This enables targeted distribution of light energy to where it is needed. In the first group of those embodiments, the optical fiber is purely end-emitting, and the end faces are arranged and guided such that the emitted light falls onto the scattering surface of the dome. In the second group of those embodiments, the optical fiber is side-emitting and extends along the inner surface of the dome in a pattern that allows light to be emitted such that the light illuminates the desired area of ​​the tissue directly and / or by scattering from the corresponding surface. A suitable pattern is, for example, wound in a spiral manner around the dome surface.

[0060] In other preferred embodiments, at least one optical fiber is guided in the upper element and / or the base, while no optical fiber is guided in the dome element. This simplifies the construction, especially when the dome element can be modularly and selectively fitted to the upper element. In such embodiments, the at least one optical fiber preferably includes an end-emitting fiber that terminates at a surface of the upper element or base that leads into the interior space defined by the dome element.

[0061] In another embodiment, individual components (base, upper element, and / or dome) include optical connectors that allow light to be routed from one component to another. The connectors may include mirrors (e.g., made of polished aluminum) and / or other waveguides. Preferably, a connection is established once the respective components are mechanically attached to each other.

[0062] In a preferred embodiment, the base has a central opening around the entry point, and the base has lateral slits connecting the central opening to the perimeter of the base. This allows the base to slide on the tubular element, even after the tubular element has been introduced into a human or animal body.

[0063] The upper part may also have lateral slits for sliding on the tubular element, even after the tubular element has been introduced into a human or animal body, wherein after the upper part is attached to the base, the upper part can rotate about the base in order to lock the tubular element in the upper part.

[0064] In this configuration, the upper portion can be shaped such that the tubular element is introduced from the top into the upper portion, extending substantially perpendicular to the body surface until the entry point. Alternatively, the upper portion is characterized by an inclined slit for introducing the tubular element. The inclined slit may have a bayonet-like geometry that allows the fiber to be locked in an end position.

[0065] In another preferred embodiment, the dome element is integral with the base, and the upper element is composed of a window element comprising a membrane made of a transparent material. Therefore, the upper element has a very simple construction and can be easily attached to the base / dome without concern for guiding or attaching tubular elements or (multiple) optical fibers.

[0066] The window element may include a scattering surface. The scattering surface may be arranged to complement the dome geometry of the base. In an embodiment, the scattering surface is substantially annular and surrounds the actual window covered by a film.

[0067] Alternatively or additionally, the material of the transparent membrane may be selected such that its inner surface facing the body scatters the illuminated light, thereby increasing the distribution within the space defined by the dome and window elements.

[0068] In a preferred embodiment, the base is made of a first material and the upper portion is made of a second material, wherein the Shore A hardness of the first material is lower than that of the second material. Specifically, the difference in Shore A hardness is at least 15. Therefore, the multi-part design of the device of the present invention allows for a relatively soft base that easily adapts to the patient's body and avoids excessive pressure on the patient's skin and irritation due to mechanical interaction. Simultaneously, the upper portion can be mechanically stable, ensuring reliable function of the device.

[0069] Furthermore, the aforementioned embodiments can be easily implemented using components made of different hardnesses, wherein the base is characterized by a flexible guide channel and the upper part is characterized by a clamping section.

[0070] As an example, the base may be made of a soft silicone rubber material with a hardness of about 30-40 Shore A, while the upper part may be made of a material that is harder than the base material (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone) with a hardness of about 50-70 Shore A.

[0071] In some embodiments, the base may be made entirely of a light-scattering material, while the upper portion may be made of a non-light-scattering material. The scattering material is one with a bidirectional reflectance distribution function (BRDF) that has a non-zero value at a certain spatial angle relative to the geometric specular ray of the incident light ray. In particular, the light-scattering surface exhibits quasi-Lambertian reflection, which maximizes the homogenization of the incident light.

[0072] In other embodiments, the upper portion may be made entirely of a light-scattering material, while the base portion may be made of a non-light-scattering material.

[0073] In a preferred embodiment, the guide for the tubular element is designed such that light emitted by at least one optical fiber housed in the guide disinfects the area of ​​the tubular element near the entry point along with the surrounding tissue. This ensures not only disinfection of the tissue but also disinfection of the catheter or other tubular element, and thus further reduces the risk of infection. Disinfection of the tubular element can be ensured by various measures such as selecting the location of the light-emitting surfaces of the (multiple) optical fibers, illuminating the main direction of the light, and providing scattering and / or reflecting surfaces to guide the light to the surface to be disinfected.

[0074] Other advantageous embodiments and combinations of features are derived from the detailed description below and the claims as a whole. Attached Figure Description

[0075] The accompanying drawings used to explain the embodiments show: Figures 1A to 1D A view of a first embodiment of the device according to the present invention; Figures 2A to 2C View of the second embodiment; Figures 3A to 3C View of the third embodiment; Figures 4A to 4D View of the fourth embodiment; Figure 5A , Figure 5B View of the fifth embodiment; Figures 6A to 6E View of the sixth embodiment; Figures 7A to 7C View of the seventh embodiment; Figures 8A to 8E View of the eighth embodiment; Figures 9A to 9C Views of the ninth embodiment; and Figures 10A to 10E View of the tenth embodiment.

[0076] In the diagram, identical components are assigned the same reference numerals. Detailed Implementation

[0077] Figures 1A to 1D This is a view of a first embodiment of the device according to the present invention. Figure 1A Showing isometric views, Figure 1B Showing a top view, Figure 1C Showing a bottom view, and Figure 1D A side view is shown.

[0078] The adapter 100 includes a base 120 and an upper portion 140, the upper portion 140 being removably attached to the base 120. The base 120 is characterized by an application portion 121 to be applied to the patient's skin surface 20 (see [link]). Figure 1D The application portion 121 has a horseshoe-shaped occupancy space with two legs 122a, 122b connected by a central portion, and has a flat lower surface that can be placed on the skin surface 20. The base 120 is made of a soft material such as silicone, and is therefore able to conform to the shape of the skin surface 20. The base 120 is further characterized by a guide channel 123 that rises from the central portion of the application portion 121 and includes a central portion consisting of two lateral elements that surround the guide channel 123 and are provided at their outer surfaces by flaps 127a, 127b. In the extension of the guide channel 123, the two lateral elements form a bend 125. The guide channel 123 extends parallel to the lower surface of the application portion 121, while the bend 125 bends downward toward the application portion 121.

[0079] The catheter 10 is housed in a guide channel 123 and a bend 125. The catheter 10 extends proximally (where it is attached to the skin surface 20, for example, at a distance from the adapter 100) through the guide channel 123 and the bend 125. After passing the bend 125, the main extension of the catheter 10 points towards the entry point in the skin surface 20. In the illustrated embodiment, the corresponding angle is approximately 45°.

[0080] The upper portion 140 forms a horseshoe-shaped clamp 141 characterized by two legs 142a and 142b. These legs 142a and 142b are accommodated between the flaps 127a and 127b of the guide channel 123 and the application portion 121 of the base 120. The lower surface of the upper portion 140 rests on the upper surface of the application portion 121. The upper portion 140 is integrally made of a material that is harder than the material of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0081] In the region of guide channel 123, base 120 is provided with four channels, each accommodating optical fibers 131.1, 131.2, 131.3, and 131.4. They enter the outer surface of base 120 in a direction substantially parallel to guide channel 123, and their positions are distributed around guide channel 123. Fiber end faces 132.1, 132.2, 132.3, and 132.4 are distributed around the distal end of bend 125 to obtain a desired illumination pattern (see...). Figure 1C ).

[0082] To attach the adapter 100 to the catheter 10, the catheter 10 is first attached to the base 120 with the upper portion 140 removed. For this purpose, the catheter 10 is introduced from above into the guide channel 123 through a slit between the two lateral elements. Due to the soft material of the base 120, the two lateral portions will easily deflect when the catheter 10 is inserted. Once the catheter is received in the guide channel 123 and the bend 125, the upper portion 140 can be inserted by sliding the two legs 142, 142b between the flaps 127a, 127b and the application portion 121 in a sliding direction parallel to the lower surface of the application portion 121 resting on the skin surface 20 and extending toward the proximal region of the catheter 10. The clamp 141 of the upper portion 140 secures the catheter 10 in the guide channel 123. Together with the bend 125, movement of the catheter 10 relative to the adapter is reliably prevented by friction.

[0083] The adapter 100 will be attached to the skin surface 20. This can be achieved using a suitable adhesive between the lower surface of the application portion 121 and the skin surface 20. Alternatively or additionally, other means, such as sutures, can be used. After attaching the adapter 100 to the catheter 10 and the skin surface 20, the adapter 100 is often covered with a transparent adhesive membrane made of a breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0084] Light can be coupled into optical fibers 131.1...4. The light exits the fiber at the distal fiber end face 132.1...4 and illuminates the skin surface 20 around the entry point. Due to the uniform distribution around the conduit 10, shadows are avoided and uniform illumination is achieved. The entry point and surrounding skin surface 20 can be inspected without removing the adapter 100 due to the window formed between the legs 122a, 122b at the base 120 and the central opening through the horseshoe-shaped upper portion 140.

[0085] Figures 2A to 2C This is a view of a second embodiment of the device according to the present invention. Figure 2A Showing isometric views, Figure 2B A front view is shown as seen from the entry point side of the device, and Figure 2C A rear view is shown as seen from the conduit and fiber supply side of the device.

[0086] The adapter 200 includes a base 220 and an upper portion 240 removably attached to the base 220. The base 220 is characterized by an application portion 221 to be applied to the patient's skin surface. The application portion 221 has a rectangular occupies space with two lateral protrusions. The application portion 221 has a flat lower surface that can be placed on the skin surface. The base 220 is made of a soft material such as silicone and is therefore adaptable to the shape of the skin surface. The base 220 is further characterized by a guide channel 223 that rises from the center of the application portion 221 and includes a central portion consisting of two lateral elements surrounding the guide channel 223 and provided at their outer surfaces by flaps 227a, 227b. In an extension of the guide channel 223, the two lateral elements form a bend 225. The guide channel 223 extends parallel to the lower surface of the application portion 221, while the bend 225 curves downward toward the application portion 221.

[0087] The catheter 10 is housed within a guide channel 223 and a bend 225. The catheter 10 extends proximally (where it is attached to the skin surface, for example, at a distance from the adapter 200) through the guide channel 223 and the bend 225. After passing the bend 225, the main extension of the catheter 10 points towards the entry point in the skin surface. In the illustrated embodiment, the corresponding angle is approximately 45°.

[0088] The upper portion 240 has a butterfly-shaped occupancy space to match the occupancy space of the application portion 221 of the base 220. The upper portion 240 is characterized by two lateral sections 243a and 243b. Both the lateral sections 243a and 243b and the application portion 221 are provided with through holes, the positions of which match when the adapter 200 is in its assembled state. The upper portion 240 forms a clamp 241 that can be accommodated between the flaps 227a and 227b of the guide channel 223 and the application portion 221 of the base 220. The lower surface of the upper portion 240 rests on the upper surface of the application portion 221. The upper portion 240 is integrally made of a material harder than that of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0089] In the region of guide channel 223, base 220 is provided with four channels, each accommodating optical fibers 231.1, 231.2, 231.3, and 231.4. They enter the outer surface of base 220 in a direction substantially parallel to guide channel 223, and their positions are distributed in the region below guide channel 223. Fiber end faces 232.1, 232.2, 232.3, and 232.4 are evenly distributed around the distal end of bend 225 (see [reference]). Figure 2B ).

[0090] To attach the adapter 200 to the catheter 10, the catheter 10 is first attached to the base 220 with the upper portion 240 removed. For this purpose, the catheter 10 is introduced from above into the guide channel 223 through a slit between the two lateral elements. Due to the soft material of the base 220, the two lateral portions will easily deflect when the catheter 10 is inserted. Once the catheter is accommodated in the guide channel 223 and the bend 225, the upper portion 240 can be inserted by sliding the clamp 241 between the flaps 227a, 227b and the application portion 221 in a sliding direction parallel to the lower surface of the application portion 221 resting on the skin surface and extending toward the distal region of the catheter 10. The clamp 241 of the upper portion 240 secures the catheter 10 in the guide channel 223. Together with the bend 225, movement of the catheter 10 relative to the adapter is reliably prevented by friction.

[0091] The adapter 200 can be specifically attached to the skin surface by stitching, wherein yarns can extend through matching through-holes in the base 220 and the upper portion 240. Alternatively or additionally, other means, such as suitable adhesives, can be used.

[0092] After the adapter 200 is attached to the catheter 10 and the skin surface, the adapter 200 is usually covered with a transparent adhesive membrane made of breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0093] Light can be coupled into optical fibers 231.1...4. The light exits the fiber at the distal fiber end face 232.1...4 and illuminates the skin surface 20 around the entry point. Due to the uniform distribution around the conduit 10, shadows are avoided and uniform illumination is achieved. The entry point and surrounding skin surface can be inspected without removing the adapter 200, as the entry point is located outside the space occupied by the adapter 200.

[0094] Figures 3A to 3C This is a view of a third embodiment of the device according to the present invention. Figure 3A Showing isometric views, Figure 3B A front view is shown as seen from the entry point side of the device, and Figure 3C A rear view is shown as seen from the conduit and fiber supply side of the device.

[0095] The adapter 300 includes a base 320 and an upper portion 340 removably attached to the base 320. The base 320 is characterized by an application portion 321 to be applied to the patient's skin surface. The application portion 321 has a rectangular occupies a space with rounded corners. The application portion 321 has a flat lower surface that can be placed on the skin surface. The base 320 is made of a soft material such as silicone and is therefore adaptable to the shape of the skin surface. The base 320 is further characterized by a guide channel 323 that rises from the center of the application portion 321 and includes a central portion consisting of two lateral elements that surround the guide channel 323 and are provided at their outer surfaces by flaps 327a, 327b. In an extension of the guide channel 323, the two lateral elements form a bend 325. The guide channel 323 extends parallel to the lower surface of the application portion 321, while the bend 325 curves downward toward the application portion 321.

[0096] The catheter 10 is housed within a guide channel 323 and a bend 325. The catheter 10 extends proximally (where it is attached to the skin surface, for example, at a distance from the adapter 300) through the guide channel 323 and the bend 325. After passing the bend 325, the main extension of the catheter 10 points towards the entry point in the skin surface. In the illustrated embodiment, the corresponding angle is approximately 45°.

[0097] The upper portion 340 occupies substantially the same space as the base portion 320. The upper portion 340 is characterized by two lateral sections 343a and 343b connected by an arch 345. Both the lateral sections 343a and 343b and the application portion 321 are provided with through holes, the corresponding through holes being positioned to match when the adapter 300 is in its assembled state. The upper portion 340 forms two clamping sections 341a and 341b, which can be accommodated between the flaps 327a and 327b of the guide channel 323 and the application portion 321 of the base portion 320. The lower surface of the upper portion 340 rests on the upper surface of the application portion 321. The upper portion 340 is integrally made of a material harder than that of the base portion (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0098] In the region of guide channel 323, base 320 is provided with four channels, each accommodating optical fibers 331.1, 331.2, 331.3, and 331.4. They enter the outer surface of base 320 in a direction substantially parallel to guide channel 323, and are located in the upper region adjacent to guide channel 323. Compared to the arrangement according to the second embodiment, this arrangement of optical fibers 331.1...4 (achieved by arch 345) reduces the risk of bending or damaging the optical fibers. Fiber end faces 332.1, 332.2, 332.3, and 332.4 are evenly distributed around the distal end of the bend 325 (see [link to previous section]). Figure 3B ).

[0099] To attach the adapter 300 to the catheter 10, the catheter 10 is first attached to the base 320 with the upper portion 340 removed. For this purpose, the catheter 10 is introduced from above into the guide channel 323 through a slit between the two lateral elements. Due to the soft material of the base 320, the two lateral portions will easily deflect when the catheter 10 is inserted. Once the catheter is accommodated in the guide channel 323 and the bend 325, the upper portion 340 can be inserted by sliding the clamp 341 between the flaps 327a, 327b and the application portion 321 in a sliding direction parallel to the lower surface of the application portion 321 resting on the skin surface and extending toward the distal region of the catheter 10. The clamp 341 of the upper portion 340 secures the catheter 10 in the guide channel 323. Together with the bend 325, movement of the catheter 10 relative to the adapter is reliably prevented by friction.

[0100] The adapter 300 can be specifically attached to the skin surface by stitching, wherein yarns extend through matching through-holes in the base 320 and the upper portion 340. Alternatively or additionally, other means, such as suitable adhesives, can be used.

[0101] After the adapter 300 is attached to the catheter 10 and the skin surface, the adapter 300 is usually covered with a transparent adhesive membrane made of breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0102] Light can be coupled into optical fibers 331.1...4. The light exits the fiber at the distal fiber end face 332.1...4 and illuminates the skin surface 20 around the entry point. Due to the uniform distribution around the conduit 10, shadows are avoided and uniform illumination is achieved. The entry point and surrounding skin surface can be inspected without removing the adapter 300, as the entry point is located outside the space occupied by the adapter 300.

[0103] Figures 4A to 4D This is a view of a fourth embodiment of the device according to the present invention. Figure 4A Showing an isometric view of the base, Figure 4B An isometric view of the base with the attached upper portion is shown. Figure 4C It is an isometric view of the complete installation, including the dome, and Figure 4D This is a side view of the complete device.

[0104] The adapter 400 includes a base 420 and an upper portion 440 removably attached to the base 420. The base 420 is characterized by an application portion 421 to be applied to the patient's skin surface. The application portion 421 is characterized by a central rectangular segment and two legs 422a, 422b extending laterally from the central segment. The application portion 421 has a flat lower surface that can be placed on the skin surface. The base 420 is made of a soft material such as silicone and is therefore adaptable to the shape of the skin surface. The base 420 is further characterized by a guide channel 423 that rises from the central segment of the application portion 421 and includes two lateral elements surrounding the guide channel 423. The guide channel 423 extends parallel to the lower surface of the application portion 421.

[0105] The catheter 10 is housed in the guide channel 423. The catheter 10 extends through the guide channel 423 from the proximal side (where it is attached to the skin surface, for example, at a distance from the adapter 400) and further extends toward the point of entry in the skin surface in a curved section.

[0106] The upper portion 440 occupies substantially the same space as the base 420. The upper portion 440 is characterized by a central portion adapted to be clamped onto the guide channel 423 of the base 420 and two lateral sections 443a, 443b that match the geometry of the legs 422a, 422b of the base 420. Both the lateral sections 443a, 443b and the legs 422a, 422b of the base 420 are provided with through holes, the positions of which match when the adapter 400 is in its assembled state. The central portion of the upper portion 440 is characterized by two longitudinal ribs 446a, 446b on its two lateral sides. The lower surface of the upper portion 440 rests on the upper surface of the application portion 421. The upper portion 440 is integrally made of a material that is harder than the material of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone), which is still flexible enough to allow snap-fit ​​attachment to the base 420.

[0107] The adapter 400 further includes a dome element 460 characterized by a base 461 and a dome 463. On its underside, the base 461 features a notch adapted to the geometry of the longitudinal ribs 446a, 446b of the upper portion 440, allowing the dome element 460 to be clamped onto the upper portion 440. The dome 463 defines a dome-shaped internal volume arranged such that it is centered on the entry point of the conduit 10 into the skin surface. On its inner surface, the dome 463 is provided with a light-scattering material, namely a polytetrafluoroethylene (PTFE) covering layer. Furthermore, in the central top region, the dome 463 is characterized by a substantially circular window 465.

[0108] Optical fiber 431 is housed within a substrate 461 of dome element 460. The distal end of optical fiber 431 extends into a volume defined by dome 463. Light emitted from the distal end is directed to the light-scattering inner surface of the dome and distributed within that volume, resulting in substantially uniform illumination of the skin surface around the point of entry. Dome 463 rises above the skin surface, thus avoiding mechanical contact. The lower edge of dome 463 is rounded to avoid irritation or injury should it temporarily come into contact with the patient's skin surface, for example, due to patient movement.

[0109] To attach the adapter 400 to the conduit 10, the conduit 10 is first attached to the base 420 with the upper portion 440 and the dome element 460 removed. For this purpose, the conduit 10 is introduced from above into the guide channel 423 through a slit between the two lateral elements. Due to the soft material of the base 420, the two lateral portions will easily deflect when the conduit 10 is inserted. Once the conduit is received in the guide channel 423, the upper portion 440 can be clamped onto the base 420 from above. The inner lateral surface of the upper portion 440 presses against the lateral elements of the guide channel 423, and thus secures the conduit 10 in the guide channel 423 by frictional engagement. Finally, the dome element 460 is clamped onto the upper portion 440.

[0110] The adapter 400 can be specifically attached to the skin surface by stitching, wherein yarns extend through matching through-holes in the base 420 and the upper portion 440. Alternatively or additionally, other means, such as suitable adhesives, can be used.

[0111] After the adapter 400 is attached to the catheter 10 and the skin surface, the adapter 400 is typically covered with a transparent adhesive membrane made of breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0112] Light can be coupled into optical fiber 431. The light exits the fiber at the distal end face of the fiber and illuminates the skin surface 20 around the entry point. Uniform illumination is achieved by avoiding shadows due to the uniform distribution obtained through the scattering surface inside the dome 463. The entry point and surrounding skin surface can be inspected without removing the adapter 400, thanks to the window 465 in the dome 463.

[0113] In a variant of the fourth embodiment, the optical fiber is characterized by a side-emitting end section that is coiled around the dome on the inner surface of the dome, thereby allowing distributed emission of light inside the dome.

[0114] Figures 5A to 5BThis is a view of the fifth embodiment of the device according to the present invention. Figure 5A It is an isometric view, and Figure 5B This is a side view of the device. The fifth embodiment broadly corresponds to the above description. Figures 4A to 4D The fourth embodiment is described. The fifth embodiment includes the same base 420 and upper portion 440, see above and... Figure 4A , Figure 4B Related descriptions. The assembly and function of the device are the same as those of the device in the fourth embodiment.

[0115] The dome element 560 differs slightly from the dome element 460 of the fourth embodiment. The dome element 560 is characterized by a base 561 and a dome 563. On its underside, the base 561 is characterized by a notch adapted to the geometry of the longitudinal ribs 446a, 446b of the upper portion 440 (see [link to documentation]). Figure 4B This allows the dome element 560 to be clamped onto the upper part 440. The dome 563 defines a dome-shaped internal volume arranged such that it is centered on the entry point of the conduit 10 into the skin surface. On its inner surface, the dome 563 is provided with a light-scattering material, namely a PTFE covering layer. Furthermore, the dome 563 is characterized by two kidney-shaped windows 565a and 565b arranged symmetrically about the longitudinal axis of the dome element 560.

[0116] Optical fiber 531 is housed in substrate 561 of dome element 560. The distal end of optical fiber 531 opens into a volume defined by dome 563. Light emitted from the distal end is directed to the light-scattering inner surface of the dome and distributed within the volume, resulting in substantially uniform illumination of the skin surface around the point of entry. Dome 563 rises above the skin surface, thus avoiding mechanical contact. Similarly, in a variant of the fifth embodiment, the optical fiber is characterized by a side-emitting end segment that coils around the dome on the inner surface of the dome, thereby allowing distributed emission of light within the dome.

[0117] Figures 6A to 6E This is a view of the sixth embodiment of the device according to the present invention. Figure 6A Showing an isometric view of the base, Figure 6B An isometric view of the base with the attached upper portion is shown. Figure 6C An isometric view is shown, including dome elements that can be attached, and Figure 6D It is a side view of the device with dome elements. Figure 6E An isometric view is shown, showing the adapter along with the supply fiber and conduit.

[0118] The adapter 600 includes a base 620 and an upper portion 640, the upper portion 640 being removably attached to the base 620. The base 620 is characterized by an application portion 621 to be applied to the patient's skin surface. The base 620 is wing-shaped and features a central raised portion and two lateral legs 622a, 622b. The legs 622a, 622b of the base 620 are provided with through holes. The application portion 621 consists of a flat lower surface that can be placed on the skin surface. The base 620 is made of a soft material such as silicone and is therefore adaptable to the shape of the skin surface.

[0119] The base 620 is further characterized by a guide channel 623, which is formed as an open channel in the central raised portion extending parallel to the lower surface of the application portion 621. The cross-section of the channel is semi-circular. Hooks 629a and 629b are arranged on both sides of the guide channel 623, extending in the vertical direction and characterized by outward-facing protrusions. A bend 625 is connected to the distal end of the guide channel 623.

[0120] The upper portion 640 occupies a generally rectangular space. It is characterized by a central portion with two openings 644a, 644b that accommodate the hooks 629a, 629b of the base 620, thus allowing the upper portion 640 to be clamped onto the base 620. The upper portion further features two lateral sections 643a, 643b. By lifting these sections, the clamping connection can be easily unlocked, allowing the upper portion 640 to be easily removed from the base 620 (if needed). Furthermore, the upper portion 640 is characterized by a curved portion 647 arranged in a longitudinal extension of the central portion. On the inner side, the upper portion 640 features a guide channel with a semi-circular cross-section. In the assembled state, the path of this guide channel extending in the central portion and the curved portion 647 matches the path of the guide channel 623 in the base 620. The upper part 640 is integrally made of a material that is harder than the material of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0121] The catheter 10 is housed in a guide channel 623 formed by a base 620 and a top 640. The catheter 10 extends proximally through the guide channel 623 (where it attaches to the skin surface, for example, at a distance from the adapter 600) and further through a bend 625 toward an entry point in the skin surface. After passing the bend 625, the main extension of the catheter 10 points toward the entry point in the skin surface. In the illustrated embodiment, the corresponding angle is approximately 45°.

[0122] The adapter 600 further includes a dome element 660 characterized by a dome 663. On its underside, the dome element 660 features a notch adapted to the geometry of the upper portion 640 and allowing the dome element 660 to be clamped onto the upper portion 640. The dome 663 defines a dome-shaped internal volume arranged such that it is centered on the entry point of the conduit 10 into the skin surface. On its inner surface, the dome 663 is provided with a light-scattering material, namely a PTFE coating. Furthermore, the dome 663 is characterized by two kidney-shaped windows 665a, 665b arranged symmetrically about the longitudinal axis of the dome element 660. The dome 663 rises above the skin surface, thus avoiding mechanical contact.

[0123] Adapter 600 is provided by fiber bundle 631, which is connected to the light source via connector 635 (see [link]). Figure 6E In the proximal portion, four fibers 631.1...4 of fiber bundle 631 extend in parallel. Fibers 631.1...4 are close to the branch of adapter 600. Downstream of the branch location, two optical fibers 631.2, 631.3 are received by base 620, and two additional optical fibers 631.1, 631.4 are received by upper portion 640. All optical fibers 631.1...4 extend substantially parallel to conduit 10. Fiber end faces are uniformly distributed around the distal ends of bends 625, 647. The end tips 646a, 646b of the upper two fibers terminate on the upper surface of bend 647. Light emitted from the end faces is directed to the light-scattering inner surface of the surface to be illuminated and / or the dome, and is thus distributed within that volume, resulting in substantially uniform illumination of the skin surface around the point of entry. In a preferred variant, the two upper optical fibers 631.1 and 631.4 have a larger cross-section than the two lower optical fibers 631.2 and 631.3. The ends of the two upper optical fibers 631.1 and 631.4 are directed to the scattering inner surface of the dome 663. In contrast, the ends of the two lower optical fibers 631.2 and 631.3 are directed to the skin surface for their direct illumination.

[0124] To attach the adapter 600 to the conduit 10, the conduit 10 is first inserted into the base 620 with the upper portion 640 and the dome element 660 removed. The conduit can be easily inserted from above into the semi-circular guide channel 623; sliding movement in the direction of the conduit is not required. Once the conduit is received in the guide channel 623, the upper portion 640 can be clamped onto the base 620 from above. Thus, the guide channel is completed, and the conduit is held by a frictional fit, which is increased by the bend. Finally, the dome element 660 is clamped onto the bend 647 of the upper portion 640.

[0125] The adapter 600 can be specifically attached to the skin surface by stitching, wherein yarn can extend through a through-hole in the base 620. Alternatively or additionally, other means, such as suitable adhesives, can be used.

[0126] After the adapter 600 is attached to the catheter 10 and the skin surface, the adapter 600 is typically covered with a transparent adhesive membrane made of breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0127] Light can be coupled into optical fibers 631.1...4. The light exits the fiber at the distal end face and illuminates the skin surface 20 around the entry point. Uniform illumination is achieved by avoiding shadows due to the uniform distribution obtained through the scattering surface inside the dome 663. The entry point and surrounding skin surface can be inspected without removing the adapter 600 due to the windows 665a, 665b in the dome 663.

[0128] In a variant of the sixth embodiment, the optical fiber is characterized by a side-emitting end section that is coiled around the dome on the inner surface of the dome, thereby allowing distributed emission of light within the dome.

[0129] In another variation of the sixth embodiment, no dome is used, and four optical fibers are used for direct illumination. In principle, a dome may or may not be used depending on the specific circumstances, as the optical fibers are completely independent of the dome element. Similarly, the dome element can be easily removed for cleaning and replaced with a new element if necessary.

[0130] Figures 7A to 7C This is a view of the seventh embodiment of the device according to the present invention. Figure 7A An isometric view of the device as seen from above is shown. Figure 7B Showing a side view, and Figure 7C An isometric view is shown, viewed from below.

[0131] The adapter 700 includes a base 720 and an upper portion 740, the upper portion 740 being removably attached to the base 720. The base 720 is formed by an annular applicator 721, which is applied to the patient's skin surface using its lower surface. In the outer ring, the base 720 has a constant first thickness, while in the inner ring, around the central circular opening 724, the thickness decreases on the upper surface, thus creating a receiving portion for the upper portion 740. A radial slit 726 extends through the outer ring. The base 720 is made of a soft material such as silicone and is therefore able to conform to the shape of the skin surface.

[0132] The upper portion 740 has the shape of a truncated cone. A larger end face is received within the inner ring of the base 720. Furthermore, a dome-shaped cavity 748 is arranged on the side of the larger end face. The inner surface of the cavity 748 is coated with a light-scattering material, namely a PTFE layer. An axial opening 743 extends through the upper portion 740, thereby connecting its smaller end face to the center of the cavity 748. The upper portion 740 further includes a radial slit 749 connecting the outer surface of the upper portion 740 to both the axial opening 743 and the cavity 748. The upper portion 740 is integrally made of a material harder than that of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0133] The catheter 10 is received in the upper opening 743. The catheter 10 extends from the smaller end face through the opening 743 and the cavity 748 toward the entry point in the skin surface.

[0134] Four optical fibers 731.1, 731.2, 731.3, and 731.4 are housed in the upper portion 740 and extend substantially parallel to the conduit 10. The fiber end faces are evenly distributed around the conduit 10 in the upper wall of the cavity 748. Light emitted from the end faces is directed to the surface to be illuminated and / or the light-scattering inner surface of the cavity 748, and is thus distributed within that volume, resulting in substantially uniform illumination of the skin surface around the point of entry.

[0135] To attach the adapter 700 to the conduit 10, the conduit 10 is first inserted into the base 720 using the slit 726. Next, the upper portion 740 slides along the conduit 10 using its slit 749. The upper portion 740 can move along the conduit 10 until the larger end face rests on the base 720. Next, the upper portion 740 rotates about its longitudinal axis to disengage its slit 749 from the slit 726 in the base 720. This ensures that the conduit 10 does not slip out.

[0136] The adapter 700 can be specifically attached to the skin surface by a suitable adhesive between the lower surface of the application portion 721 and the skin surface. After attaching the adapter 700 to the catheter 10 and the skin surface, the adapter 700 is usually covered with a transparent adhesive membrane made of a breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall). In particular, the adapter 700 is sandwiched between two parts of the membrane.

[0137] Light can be coupled into optical fibers 731.1...4. The light will exit the fiber at the distal end face of the fiber and illuminate the skin surface around the point of entry. Due to the uniform distribution obtained through the scattering surface inside cavity 748, shadows are avoided and uniform illumination is achieved.

[0138] The device according to the seventh embodiment is particularly suitable for application to catheters attached to the human body via a so-called "finger trap" technique, wherein the catheter is attached to the leather skin via a single needle at the puncture site, and the two ends of a suture are wrapped around the catheter like a finger trap. The ends of the suture are tied together at the slit in the lumen. In these cases, the device is placed around the catheter after catheter insertion and suturing.

[0139] Figures 8A to 8E This is a view of the eighth embodiment of the device according to the present invention. Figure 8A An isometric view of the device prior to the attachment of window elements is shown. Figure 8B It is an isometric view of a device with attached window elements. Figure 8C It is a top view. Figure 8D It is a front view as seen from the entry point side of the device, and Figure 8E A rear view is shown as seen from the conduit and fiber supply side of the device.

[0140] The adapter 800 includes a base 820 and an upper portion 840, the upper portion 840 being removably attached to the base 820. The base 820 is formed by an annular applicator 821, which is applied to the patient's skin surface using its lower surface. In the outer ring, the base 820 has a constant first thickness, and in the inner ring, around a central circular opening 824, the base 820 forms a dome 828, i.e., a raised section defining a dome-shaped cavity. The inner surface of the dome 828 is provided with a light-scattering material, i.e., a PTFE covering layer. A radial slit 826 extends through the applicator 821 and the dome 828. The base 820 is made of a soft material such as silicone and is therefore able to conform to the shape of the skin surface.

[0141] The upper part 840 is substantially disc-shaped, thus having a circular footprint and a radial slit 849. The upper part 840 may be characterized as a window covered by a transparent material.

[0142] Optical fiber 831 extends into base 820 and branches into four fiber branches 833a, 833b, 833c, and 833d. From the channel leading to dome 828, two of the branches 833a and 833b extend to the left, while two of the branches 833c and 833d extend to the right. Two branches 833b and 833d, each on one side, terminate near the channel, while two branches 833a and 833d, each on one side, terminate in the region adjacent to the slit 826 in base 820. Light emitted from the end face is directed to the surface to be illuminated and / or the light-scattering inner surface of dome 828, and thus distributed within that volume, resulting in substantially uniform illumination of the skin surface around the point of entry.

[0143] The upper part 840 may be characterized by an additional scattering surface, thereby improving the distribution of light within the dome 828.

[0144] After the catheter is implanted into the body, the adapter 800 is attached to the catheter, for example, using the "finger trap" technique mentioned above. The base 820 slides over the catheter 10 using a slit 826 and is attached to the skin, for example, using a suitable adhesive. Next, the upper portion 840 is attached to the base 820. For this purpose, a suitable adhesive is provided on the lower surface of the upper portion 840. The catheter 10 extends through the slit 849 of the upper portion 840.

[0145] After the adapter 800 is attached to the catheter 10 and the skin surface, the adapter 800 is usually covered with a transparent adhesive membrane made of breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0146] Figures 9A to 9C This is a view of the ninth embodiment of the device according to the present invention. Figure 9A The image shows isometric views of the base and upper portion before they are attached together. Figure 9B An isometric view of the base with the attached upper portion is shown. Figure 9C This is a front view of the complete device.

[0147] The adapter 900 includes a base 920 and an upper portion 940, the upper portion 940 being removably attached to the base 920. The base 920 is characterized by an application portion 921 to be applied to the patient's skin surface. The application portion 921 has a generally triangular occupies space. The application portion 921 has a flat lower surface that can be placed on the skin surface. The base 920 is made of a soft material such as silicone, and is therefore able to conform to the shape of the skin surface. Through holes 922a, 922b, and 922c are provided in the application portion 921 near the three corners.

[0148] The base 920 is further characterized by an elevated central portion 924 and a guide channel 923, the elevated central portion 924 having a generally circular shape, and the guide channel 923 extending parallel to the lower surface of the application portion 921 from the circular portion to one of the edges of the base 920. The sides of the central portion 924 extending substantially parallel to the guide channel 923 are flattened and form a guide for the upper portion 940.

[0149] The catheter can be accommodated in the guide channel 923. The catheter extends through the guide channel 923 from the proximal side (where it is attached to the skin surface, for example, at a distance from the adapter 900) and further extends toward the entry point in the skin surface in a curved section.

[0150] The upper portion 940 can be attached to the base 920 by sliding movement parallel to the guide channel 923. The upper portion 940 has a smaller footprint than the base 920, so that the through holes 922a...c remain accessible even after the upper portion 940 is attached to the base 920. The upper portion 940 has a generally rectangular external shape with several notches to improve grip on the upper portion 940 when manipulating it. The internal shape is generally circular with straight lateral segments to match the geometry of the central portion 924 of the base 920. The upper surface of the upper portion 940 is characterized by a circular window 951 that matches the size and position of the inner edge of the circular segment of the central portion 924 in the base 920. The upper portion 940 is integrally made of a material that is harder than that of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0151] Optical fiber 931 is housed in upper portion 940. The distal end of optical fiber 931 opens into the volume defined by the circular portion of central portion 924 of base 920 and upper portion 940. Light emitted from the distal end is directed in particular to the light-scattering inner surfaces of central portion 924 of base 920 and upper portion 940, and distributed within this volume, resulting in substantially uniform illumination of the skin surface around the point of entry.

[0152] To attach the adapter 900 to the catheter, the guide channel 923 of the base 920 slides over the catheter from above. Next, the base 920 can be attached to the skin surface, for example by suturing, using through-holes 922a...c. Alternatively or additionally, other means, such as suitable adhesives, can be used.

[0153] Next, the upper part 940 slides on the center part 924 of the base 920. The internal geometry of the upper part 940 matches the external geometry of the guide channel 923, and thus when the upper part 940 is attached to the base 920, the guide is fixed in the guide channel 923 by friction fit.

[0154] After the adapter 900 is attached to the catheter and the skin surface, it is usually covered with a transparent adhesive membrane made of breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0155] Light can be coupled into optical fiber 931. The light exits the fiber at the distal end face of the fiber and illuminates the skin surface around the entry point. Due to the uniform distribution obtained through the scattering surface, shadows are avoided and uniform illumination is achieved. Thanks to the window 951 in the upper part 940, the entry point and surrounding skin surface can be inspected without removing the adapter 900.

[0156] Figures 10A to 10E This is a view of the tenth embodiment of the device according to the present invention. Figure 10A Showing isometric views, Figure 10B Only the rear view of the base is shown. Figure 10C Showing a bottom view, and Figure 10D A side view is shown. Figure 10E This is an isometric view of the light guide within the adapter.

[0157] The adapter 1000 is constructed and functions very similarly to the adapter of the first embodiment. The main difference relates to light distribution. The adapter 1000 includes a base 1020 and an upper portion 1040, which is removably attached to the base 1020. The base 1020 is characterized by an application portion 1021 to be applied to the patient's skin surface. The application portion 1021 has a horseshoe-shaped occupancy space with two legs 1022a, 1022b connected by a central portion, and has a flat lower surface that can be placed on the skin surface. The base 1020 is made of a soft material such as silicone, and is therefore able to conform to the shape of the skin surface. The base 1020 is further characterized by a guide channel 1023 that rises from the central portion of the application portion 1021 and includes a central portion consisting of two lateral elements that surround the guide channel 1023 and are provided at their outer surfaces by flaps 1027a, 1027b. In the extension of the guide channel 1023, two lateral elements form a bend 1025. The guide channel 1023 extends parallel to the lower surface of the application portion 1021, while the bend 1025 bends downward toward the application portion 1021.

[0158] The catheter can be accommodated in the guide channel 1023 and the bend 1025. The catheter extends proximally (where it is attached to the skin surface, for example, at a distance from the adapter 1000) through the guide channel 1023 and the bend 1025. After passing the bend 1025, the main extension of the catheter points towards the entry point in the skin surface. In the illustrated embodiment, the corresponding angle is approximately 45°.

[0159] The upper portion 1040 forms a horseshoe-shaped clamp 1041 characterized by two legs 1042a and 1042b. These legs 1042a and 1042b are accommodated between the flaps 1027a and 1027b of the guide channel 1023 and the application portion 1021 of the base 1020. The lower surface of the upper portion 1040 rests on the upper surface of the application portion 1021. The horseshoe-shaped clamp 1041 surrounds a dome-shaped cavity having a generally hemispherical internal shape. The inner surface of the cavity is coated with a light-scattering material, such as PTFE. The cavity is further characterized by a window 1051. The upper portion 1040 is integrally made of a material that is harder than the material of the base (e.g., polyethylene (PE), polypropylene (PP), or a harder silicone).

[0160] The light distribution system of the adapter 1000 is housed in the base 1020. The light distribution system includes a supply fiber bundle 1031 entering the base 1020, which branches into six individual fibers 1031.1...6 within the base. Two top fibers 1031.1, 1031.2 terminate in the top section of the bend 1025. The ends of the two top fibers 1031.1, 1031.2 are upwardly directed, with their central illumination axes pointing towards a scattering surface inside the cavity. Two intermediate fibers 1031.3, 1031.4 terminate in small hemispherical cavities on the side surface of the bend 1025. The illumination axes of the two intermediate fibers 1031.3, 1031.4 point substantially parallel to the lower surface of the application portion 1021 and parallel to the central plane of the adapter 1000 defined by the path of the conduit. The light from the two intermediate fibers 1031.3 and 1031.4 is distributed by corresponding cavities, which are also coated with a light-scattering material such as PTFE. The bottom fibers 1031.5 and 1031.6 terminate in the region below the bend 1025, in another cavity, and point slightly upwards. The light from the bottom fibers 1031.5 and 1031.6 is scattered within the cavity to primarily illuminate the area below the conduit, which can be partially blocked from receiving light distributed by the scattering surfaces within the cavity.

[0161] To attach the adapter 1000 to the catheter, the catheter is first attached to the base 1020 with the upper portion 1040 removed. For this purpose, the catheter is introduced from above into the guide channel 1023 through a slit between the two lateral elements. Due to the soft material of the base 1020, the two lateral portions will easily deflect when the catheter is inserted. Once the catheter is accommodated in the guide channel 1023 and the bend 1025, the upper portion 1040 can be inserted by sliding the two legs 1042a, 1042b between the flaps 1027a, 1027b and the application portion 1021 in a sliding direction parallel to the lower surface of the application portion 1021 resting on the skin surface and extending toward the proximal region of the catheter. The clamp 1041 of the upper portion 1040 secures the catheter in the guide channel 1023. Together with the bend 1025, movement of the catheter relative to the adapter is reliably prevented by friction.

[0162] The adapter 1000 will be attached to the skin surface. This can be achieved using a suitable adhesive between the lower surface of the application portion 1021 and the skin surface. Alternatively, other means, such as sutures, can be used. After attaching the adapter 100 to the catheter and the skin surface, the adapter 100 is often covered with a transparent adhesive membrane made of a breathable material. Such membranes are commonly used in hospital settings and are commercially available, for example, from 3M (Tegaderm), Molnlycke (Mepitel), or Covidien (Kendall).

[0163] Light is coupled into optical fibers 1031.1...6 of fiber bundle 1031. The light exits the fiber at the distal fiber end face 1032.1...6 and illuminates the entire skin surface around the entry point. The entry point and surrounding skin surface can be inspected without removing adapter 1000 due to window 1051 in the upper portion. The invention is not limited to the described embodiments. In particular, an element of one embodiment can be combined with an element of another embodiment. Furthermore, the geometry of individual elements can be selected differently. Various other options exist for guiding optical fibers or fiber bundles. End-emitting fibers can be combined with side-emitting fibers within the same device. Furthermore, the emission geometry of individual fibers can be selected differently, and additional optical elements can be used to scatter, reflect, or distribute light after emission from the fibers.

[0164] In summary, it should be noted that the present invention provides an apparatus for guiding a tubular element near an entry point into a human or animal body and for disinfecting tissue around the entry point. This apparatus allows for reliable disinfection of tissue around the entry point of the tubular element into the human or animal body and is easy and safe to use.

Claims

1. An apparatus for guiding a tubular element near an entry point into a human or animal body and for disinfecting tissue around the entry point by applying light, the apparatus comprising: a) A base adapted to be attached to the body of the person or animal near the point of entry; b) The upper portion, which is adapted to be removably attached to the base portion; in c) The base and / or the upper portion form a guide for the tubular element; d) The base and / or the upper portion guide at least one optical fiber along the guide for the tubular element, the optical fiber having at least one emitting surface for emitting light to illuminate the tissue around the point of entry when the base is attached to the body; and e) The upper portion is adapted to be attached to and removed from the base after the tubular element has been introduced into the human or animal body.

2. The apparatus according to claim 1, characterized in that, The guide for the tubular element is arranged such that, in at least one section, the center of the receiving space for the tubular element is at least 2 mm, and in particular at least 3 mm, from the attachment surface of the base for attaching the device to the body of the person or animal.

3. The apparatus according to claim 2, characterized in that, The guide for the tubular element includes a curved section that guides the received tubular element from an initial direction generally parallel to the attachment surface of the base to an inclined direction toward the entry point.

4. The apparatus according to claim 3, characterized in that, In the attachment configuration of the upper part on the base, the curved section of the guide for the tubular element is formed between the lower guide in the base and the upper guide in the upper part, wherein, in particular, at least one optical fiber is guided in the lower guide and at least one additional optical fiber is guided in the upper guide.

5. The apparatus according to any one of claims 1 to 4, characterized in that, The at least one emitting surface of the at least one optical fiber is located at the distal end of the fiber, wherein the distal end is positioned in the region surrounding the distal end of the guide for the tubular element.

6. The apparatus according to claim 5, characterized in that, At least two optical end-emitting fibers terminate in the region surrounding the distal end of the guide.

7. The apparatus according to claim 5, characterized in that, The device includes a single optical fiber, particularly an end-emitting fiber.

8. The apparatus according to any one of claims 1 to 7, characterized in that, The base and / or the upper portion form a flexible guide channel for guiding the tubular element, and the upper portion and / or the base includes a clamping section for selectively compressing the flexible guide channel and the tubular element housed in the flexible guide channel in order to lock the tubular element in the flexible guide channel.

9. The apparatus according to claim 8, characterized in that, The flexible guide channel is formed in the base, and the clamping section is formed in the upper portion, wherein the upper portion is slidably attached to the base, and wherein the sliding direction for attaching the upper portion to the base is particularly parallel to the extension of the guide for the tubular element.

10. The apparatus according to any one of claims 1 to 9, characterized in that, The surfaces of the base and / or the upper portion illuminated by the light emitted by the optical fibers are made of a biocompatible UVC-resistant material, particularly of materials selected from: PTFE, aluminum, alumina, magnesium oxide, titanium, titanium oxide, and other ceramic materials.

11. The apparatus according to any one of claims 1 to 10, characterized in that, The distal end of the fiber is surrounded by a cavity formed of or coated with a scattering material.

12. The apparatus according to any one of claims 1 to 11, characterized in that... A dome element for distributing light emitted by the at least one optical fiber in order to homogenize the illumination of the tissue around the point of entry.

13. The apparatus according to claim 12, characterized in that, The dome element includes a surface made of a light-scattering material, wherein light emitted by the at least one optical fiber is at least partially directed to the surface.

14. The apparatus according to claim 13, characterized in that, The surface is curved.

15. The apparatus according to claim 13, characterized in that, The surface is flat.

16. The apparatus according to any one of claims 12 to 15, characterized in that, The dome element includes at least one window that allows inspection of the tissue surrounding the entry point.

17. The apparatus according to claim 16, characterized in that, The at least one window is covered by a membrane made of a transparent material, particularly a breathable transparent material.

18. The apparatus according to any one of claims 12 to 17, characterized in that, The dome element is adapted to be selectively attached to the upper element.

19. The apparatus according to claim 18, characterized in that, The at least one optical fiber is guided in the dome element.

20. The apparatus according to claim 18, characterized in that, At least one optical fiber is guided in the upper element and / or in the base, while no optical fiber is guided in the dome element.

21. The apparatus according to any one of claims 1 to 20, characterized in that, The base has a central opening for surrounding the entry point, and the base has lateral slits connecting the central opening to the periphery of the base for sliding the base on the tubular element, even after the tubular element has been introduced into the human or animal body.

22. The apparatus according to claim 21, characterized in that, The upper portion has a lateral slit for sliding on the tubular element, even after the tubular element has been inserted into the human or animal body, wherein, after the upper portion is attached to the base, the upper portion is rotatable about the base in order to lock the tubular element in the upper portion.

23. The apparatus according to claims 17 and 21, characterized in that, The dome element is integral with the base, and the upper element is composed of a window element comprising a membrane made of the transparent material.

24. The apparatus according to any one of claims 1 to 23, characterized in that, The base is made of a first material and the upper part is made of a second material, wherein the Shore A hardness of the first material is lower than that of the second material, and the difference in Shore A hardness is specifically at least 15.

25. The apparatus according to any one of claims 1 to 24, characterized in that, The base is made entirely of light-scattering material, and the upper part is made of non-light-scattering material.

26. The apparatus according to any one of claims 1 to 25, characterized in that, The guide for the tubular element is designed such that light emitted by the at least one optical fiber housed in the guide disinfects the area of ​​the tubular element near the entry point along with the tissue surrounding the entry point.

27. The apparatus according to any one of claims 1 to 26, characterized in that, The tubular element is one of the following: a) Catheters, especially central venous catheters, catheters for external ventricular drainage, catheters for extracorporeal membrane oxygenation, catheters for dialysis, or catheters for long-term drug administration. b) Lines used for transmitting electrical or optical signals, particularly lines used for transmitting electrical or optical signals to and / or from the brain of a human or animal or to an implanted medical device. c) Circuits used to specifically supply electrical energy to implanted medical devices.

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